Misoprostol for Reduction of Blood Loss During Fibroid Surgery

Phase 4

Terminated

Brief Summary: The aim of this research work is to assess the impact of a single preoperative dose of buccal misoprostol in reducing blood loss during abdominal fibroid surgery.

Detailed Description: This is a trial of women undergoing fibroid surgery at a university-affiliated tertiary care center. Eligible participants will be randomized to receive preoperative 400ucg buccal (under the tongue) misoprostol or placebo on the basis of total fibroid volume, location, parity. Intra-operative blood loss will be compared between groups.

Recruitment & Eligibility

Inclusion Criteria

Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging (pelvic ultrasound or MRI) within in last 12 months
Age ≥ 18 years and ≤ 50 years
Pre-operative hemoglobin >8 g/dl
Willing to have buccal administration of misoprostol or a placebo at least one hour pre-procedure.
Ability to understand and the willingness to sign a written informed consent.
Admissible medical/surgical history
Can be previously treated with Depo-Lupron, Depo-Provera, or Oral Contraceptive pills
Intraoperative use of vasopressin and uterine tourniquet is permissible
Can have had prior Cesarean delivery

Exclusion Criteria

Patients who have had a prior abdominal myomectomy
Post-menopausal women
Patients with known bleeding/clotting disorders
Patients with a history of gynecologic malignancy
History of allergic reactions attributed to compounds of similar chemical or biologic composition to misoprostol
Any cases converted to abdominal hysterectomy or other additional elective surgical procedures performed at time of abdominal myomectomy will be excluded from data analysis
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
Misoprostol	Misoprostol	25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.

Primary Outcome Measures

Name	Time	Method
Estimated Intra-operative Blood Loss	Intra-operative	Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.

Secondary Outcome Measures

Name	Time	Method
Duration of Procedure	Intra-operative	Intra-operative time
Length of Inpatient Hospitalization	Number of days the patient is hospitalized post-operatively, an expected average of 3 days and a maximum of 90 days post-operatively	Participants will be followed for the duration of their stay, defined as the number of days of post-operative inpatient hospitalization, an expected average of 3 days.
Post-operative Blood Transfusion	From time of surgery completion through discharge from hospital, an expected average period of 3 days	Whether or not a patient receives a post-operative blood transfusion, defined as a transfusion occurring in the immediate post-operative period (during post-operative inpatient hospitalization).